PK Study of YH22189 FDC Compared to Combination of Telmisartan/Amlodipine and Rosuvastatin

Phase 1

Terminated

• Conditions: Hypertension; Hyperlipidemia
• Interventions: Drug: Crestor 20mg; Drug: Twynsta 80/10mg; Drug: YH22189

• Registration Number: NCT02608242
• Lead Sponsor: Yuhan Corporation

Brief Summary

This is a Randomized, open-label, single-dose, 3-treatment, 3-period, 3-sequence crossover design.

Detailed Description

This is a 6 by 3 cross-over study to evaluate pharmacokinetics of YH22189 FDC compared to reference telmisartan/amlodipine and rosuvastatin co-administered in three groups enrolling healthy adult male subjects under fasting conditions.

Subjects will be admitted to the clinic in the evening before Day 1. All subjects will receive a single oral dose of YH22189 FDC or telmisartan/amlodipine or rosuvastatin administered in the morning on Day 1. All the subjects will remain in the clinical unit until completion of all assessments on Day 2 including collection post-dose PK sample. Subjects will return to the clinic for pharmacokinetic samples at scheduled time. The three treatment periods will be separated by a washout period.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-11
• Study First Submitted QC: 2015-11-16
• Study First Posted: 2015-11-18
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 123

Inclusion Criteria

• Healthy male and female with a body mass index(BMI) between 18.5 and 25 kg/m2
• Who has not suffered from clinically significant disease
• Provision of signed written informed consent

Exclusion Criteria

• History of and clinically significant disease
• A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
• Administration of other investigational products within 3 months prior to the first dosing
• Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs
• Sitting blood pressure meeting the following criteria at screening: 150 ≥ systolic blood pressure ≤100 (mmHg) and 100 ≥ diastolic blood pressure ≤ 60 (mmHg)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Crestor 20mg	Crestor 20mg	Rosuvastatin 20mg
Twynsta 80/10mg	Twynsta 80/10mg	Telmisartan/Amlodipine 80/10mg (FDC)
YH22189	YH22189	YH22189 FDC tablet of Yuhan Corporation

Primary Outcome Measures

Name	Time	Method
Telmisartan Cmax	0 - 72 hrs
Telmisartan AUClast	0 - 72 hrs
Amlodipine Cmax	0 - 168 hrs
Amlodipine AUClast	0 - 168 hrs
Rosuvastatin Cmax	0 - 48 hrs
Rosuvastatin AUClast	0 - 48 hrs

Trial Locations

Locations (1)

Chonbuk National University Hospital; 🇰🇷 Chunju, Korea, Republic of